Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Dentine Hypersensitivity Clinical Trial

Official title:

A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827670
• Other study ID #: RH01685
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2013
• Last updated: January 22, 2015
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: January 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.

• Participants with minimum of 20 natural teeth.

• At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.

1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.

2. Teeth with Gingival Index score =1 and a clinical mobility of =1.

3. Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Exclusion Criteria:

• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.

• Any condition which, in the opinion of the investigator, causes dry mouth.

• Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.

• Participant using of a desensitising dentifrice within 6 weeks of screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Stannous fluoride
Test dentifrice containing 0.454% SnF
• Sodium monofluorophosphate
Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]

Locations

Country	Name	City	State
United States	Salus Research, Inc.	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Schiff Sensitivity Score	The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).; Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation	Baseline-Week 8	No
Secondary	Mean Change From Baseline in Schiff Sensitivity Score	The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).; Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation	Baseline-Week 4	No
Secondary	Mean Change From Baseline in Tactile Sensitivity	The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.	Baseline-Week 8	No
Secondary	Mean Change From Baseline in Tactile Sensitivity	The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.	Baseline-Week 4	No
Secondary	Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)	The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF	Baseline-Week 4	No
Secondary	Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)	The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF	Baseline - Week 8	No